Systems and methods for applying tissue-piercing fasteners

ABSTRACT

Systems and methods introduce a tissue fastener applier to apply tissue-piercing fasteners to a prosthesis sequentially along a path established by the directing device that, between fastener applications, is manipulated into orientation with different desired fastening sites, until a plurality of tissue-piercing fasteners are placed, one-at-a-time, in the prosthesis.

RELATED APPLICATION

This application is a divisional of co-pending U.S. patent applicationSer. No. 11/166,411, filed Jun. 24, 2005 entitled “Endovascular AneurysmRepair System,” which is a divisional of U.S. patent application Ser.No. 10/271,334 filed Oct. 15, 2002 (now U.S. Pat. No. 6,960,217), whichclaims the benefit of U.S. provisional application Ser. No. 60/333,937filed Nov. 28, 2001.

BACKGROUND OF THE INVENTION

The invention relates generally to the attachment of a vascularprosthesis to a native vessel, and in particular, to a method and systemof devices for the repair of diseased and/or damaged sections of avessel.

Description of Related Art. The weakening of a vessel wall from damagedor diseased can lead to vessel dilatation and the formation of ananeurysm. Left untreated, an aneurysm can grow in size and willeventually rupture.

For example, aneurysms of the aorta primarily occur in abdominal region,usually in the infrarenal area between the renal arteries and the aorticbifurcation. Aneurysms can also occur in the thoracic region between theaortic arch and renal arteries. The rupture of an aortic aneurysmresults in massive hemorrhaging and has a high rate of mortality.

Open surgical replacement of a diseased or damaged section of vessel caneliminate the risk of vessel rupture. In this procedure, the diseased ordamaged section of vessel is removed and a prosthetic graft, made eitherin a straight of bifurcated configuration, is installed and thenpermanently attached and sealed to the ends of the native vessel bysuture. The prosthetic grafts for these procedures are usuallyunsupported woven tubes and are typically made from polyester, ePTFE orother suitable materials. The grafts are longitudinally unsupported sothey can accommodate changes in the morphology of the aneurysm andnative vessel. However, these procedures require a large surgicalincision and have a high rate of morbidity and mortality. In addition,many patients are unsuitable for this type of major surgery due to otherco morbidities.

Endovascular aneurysm repair has been introduced to overcome theproblems associated with open surgical repair. The aneurysm is bridgedwith a vascular prosthesis, which is placed intraluminally. Typicallythese prosthetic grafts for aortic aneurysms are delivered collapsed ona catheter through the femoral artery. These grafts are usually designedwith a fabric material attached to a metallic scaffolding (stent)structure, which expands or is expanded to contact the internal diameterof the vessel. Unlike open surgical aneurysm repair, intraluminallydeployed grafts are not sutured to the native vessel, but rely on eitherbarbs extending from the stent, which penetrate into the native vesselduring deployment, or the radial expansion force of the stent itself isutilized to hold the graft in position. These graft attachment means donot provide the same level of attachment when compared to suture and candamage the native vessel upon deployment.

Accordingly, there is a need for an endovascular aneurysm repair systemthat first provides a prosthetic graft, which can adapt to changes inaneurysm morphology and be deployed without damaging the native vesseland second, a separate endovascular fastening system that providespermanent graft attachment to the vessel wall.

SUMMARY OF THE INVENTION

The methods and apparatus for implanting radially expandable prosthesesin body lumens are described. In particular, the present inventionprovides improved methods and systems for implanting vascular stents andstent-grafts into blood vessels, including both arterial and venoussystems. In the exemplary embodiments, stent-grafts are placed invasculature to reinforce aneurysms, particularly abdominal aorticaneurysms.

One aspect of the invention provides systems and methods for introducinga tissue fastener applier to apply tissue-piercing fasteners to a bodyorgan sequentially along a path established by the directing devicethat, between fastener applications, is manipulated into orientationwith different desired fastening sites, until a plurality oftissue-piercing fasteners are placed, one-at-a-time, in the prosthesis.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be understood from the following detailed descriptionof preferred embodiments, taken in conjunction with the accompanyingdrawings, wherein:

FIG. 1 is a perspective view of one embodiment of an endovascular graftdelivery device shown positioned within an abdominal aortic aneurysm;

FIG. 2 is a perspective view of one embodiment the deployment of anendovascular graft within the aneurysm of FIG. 1;

FIG. 3 is a perspective view of a fully deployed straight endovasculargraft of FIG. 2;

FIG. 4 is a perspective view of a fully deployed bifurcated endovasculargraft broken away to show an anchoring scaffold at one end;

FIG. 5 is a perspective view similar to FIG. 5 showing an alternativescaffold structure;

FIG. 6 is a perspective view showing one embodiment of a device fordirecting the fastener applier;

FIG. 7 is a perspective view showing the device of FIG. 6 upon insertionwithin the deployed endovascular graft of FIG. 3 with both the graft andscaffolding broken away;

FIG. 8 is a perspective view of the device of FIG. 6 showing activationof one embodiment of a stabilizing device attached to the directingdevice;

FIG. 9 is a perspective view of the control assembly in FIG. 8articulating the directing device of FIG. 6;

FIG. 10 is a perspective view of an alternative embodiment of thestabilization device of FIG. 8;

FIG. 11 is a perspective view showing the activation of the alternativestabilization device of FIG. 10;

FIG. 12 is a perspective view showing another embodiment of thestabilization device of FIG. 8;

FIG. 13 is a perspective view showing activation of the stabilizationdevice of FIG. 12;

FIG. 14 is one embodiment of the fastener applier;

FIG. 15 is a perspective view of the fastener applier of FIG. 14 beingpositioned within directing device of FIG. 6;

FIG. 16 is an enlarged cross-sectional view of one embodiment of thefastener applier of FIG. 14;

FIG. 17 is an enlarged cross-sectional view of the attachment appliershowing one embodiment of the proximal end of the helical fastener andthe drive mechanism;

FIG. 18 is a enlarged perspective view of one embodiment of the helicalfastener of FIG. 16;

FIG. 19 is an enlarged view of the attachment applier showing oneembodiment of the control assembly that activates the fastener applier;

FIG. 20 is an enlarged view of the attachment applied activated with afastener implanted into the graft and vessel wall;

FIG. 21 is an enlarged view of the completed attachment of the proximalgraft of FIG. 3 to the vessel wall with fasteners;

FIG. 22 is a perspective view of the graft of FIG. 4 completely attachedto the vessel.

Detailed Description of the Invention

FIG. 1 depicts an endovascular graft delivery catheter 10 beingpositioned within an abdominal aortic aneurysm 11 over a guidewire 12.FIG. 2 depicts the initial stage of graft deployment within a vessel.The delivery catheter 10 has a movable cover 13 over the graft. When thecover is pulled proximally the graft 14 expands to contact the internalwalls of the vessel. It is contemplated that the graft could beself-expanding or utilize an expanding member such as a balloon ormechanical expander. The process of graft deployment is continued untilthe graft is fully deployed within the vessel. It is contemplated thatthe graft could be in either a straight or bifurcated form. FIG. 3depicts a completely deployed straight graft 14 and FIG. 4 depicts acompletely deployed bifurcated graft 15. The guidewire 11 used todeliver and position the graft remains within the vessel for access ofthe fastener attachment system. One embodiment of the graft scaffolding16 (stent) is illustrated in the area broke away in FIG. 4. The stent isin the form of a simple zigzag pattern, however it is contemplated thatthe stent design could involve more complex patterns 17 as depicted inFIG. 5. Although only one stent structure within the graft is depicted,in FIGS. 4 and 5, it is contemplated that multiple independent stentstructures could be incorporated into the graft. 1391 FIG. 6 depicts oneembodiment of the directing device 18 with an obturator 19 positionedwithin the lumen of the directing device and extending past the distalof the tip of the directing device. The obturator has a lumen to allowfor delivery over a guidewire. FIG. 7 depicts the directing device beingpositioned within the deployed endovascular graft over a guidewire 12.The directing device has an incorporated stabilizing device 20 to aid inmaintaining position of the directing device within the vessel. In oneembodiment, the stabilizing device 20 is spring-loaded and is positionedfor use when the obturator in the directing device is removed FIG. 8.The directing device is activated though a control assembly 21 as seenin FIG. 8. In one embodiment the control assembly 21 features a movablewheel or lever 22, which deflects the distal tip 23 of the directingdevice 18 to the desired location as seen in FIG. 9. It is contemplatedthat the control assembly for the directing device could be activatedmechanically, electrically, hydraulically or pneumatically. The controlassembly has a through lumen to allow for the passage of the obturatorand fastener applier. FIG. 10 depicts another embodiment the stabilizingdevice as a movable strut assembly 24. The movable strut assembly isactivated through a lever 25 on the control assembly FIG. 11. In bothembodiments (FIG. 7 and 10) the stabilizing device is distal to the endof the directing device. In another embodiment the stabilizing devicecould be in the form of an expandable member 26 adjacent to the distaltip of the directing device FIG. 12. In one embodiment, the expandablemember 26 is shown activated through a lever 25 on the control assemblyFIG. 13. However it also contemplated that this type of stabilizingdevice could also be inflatable. In all embodiments the stabilizingdevice could be use to stabilize the directing member eitherconcentrically or eccentrically within the vessel.

In another embodiment of the invention a separate tubular device couldbe used in cooperation with the directing device and to access thevessel. This separate tubular device could incorporate the stabilizingdevices used above with the directing device.

FIG. 14 depicts one embodiment of the fastener applier 27. FIG. 14A is adetail view of the distal end of the fastener applier. FIG. 15 depictsthe fastener applier being positioned through the lumen of the directingdevice to the site where a fastener will be installed.

FIG. 16 is an enlarged cross-sectional view of fastener applier 27 anddirecting device 18. In one embodiment of the fastener applier thehelical fastener 28 is rotated via a fastener driver 29 through a driveshaft 30 that is connected to the control assembly 31. The drive shaft30 can be made of any material that allows for both bending androtation. The drive shaft is connected to the fastener driver 29, whichengages and imparts torque to the helical fastener. FIG. 16 illustratesthe coils of the helical fastener 28 engaged with internal grooves 32within the fastener applier. It is contemplated that the grooves couldbe positioned along the entire length of the fastener or within aportion of its length. FIG. 17 is an enlarged cross-sectional view ofthe fastener applier 27 with a cross-section of the fastener driver 29depicting one embodiment of engagement between the fastener driver andhelical fastener 28. In this embodiment the proximal coil of the helicalfastener is formed to produce a diagonal member 33, which crosses thediameter of the helical fastener. Similar helical fasteners aredescribed in U.S. Pat. Nos. 5,964,772; 5,824,008; 5,582,616; and6,296,656, the full disclosures of which are incorporated herein byreference.

FIG. 18 depicts one embodiment of the helical fastener 28 showing thediagonal member 33. FIG. 19 depicts one embodiment of the fastenerapplier 27 during activation of the fastener applier control assembly.Activation of the control assembly rotates the drive shaft, fasterdriver and helical fastener. This rotation causes the helical fastener28 to travel within the internal grooves 32 of the fastener applier andinto the graft 14 and vessel wall 34 FIG. 20. It is contemplated thatthe control assembly for the fastener applier could be activatedmechanically, electrically, hydraulically or pneumatically.

FIG. 21 illustrates a completed helical fastener 28 attachment of thegraft 14 to the vessel wall 34. It is contemplated that one or morefasteners will be required to provide secure attachment of the graft tothe vessel wall.

FIG. 22 illustrates a perspective view of a graft prosthesis attached tothe vessel wall both proximally and distally. It is contemplated thatthe present invention can be used for graft attachment of both,straightand bifurcated grafts 15 within the aorta and other branch vessels.

It will be appreciated that the components and/or features of thepreferred embodiments described herein may be used together orseparately, while the depicted methods and devices may be combined ormodified in whole or in part. It is contemplated that the components ofthe directing device, fastener applier and helical fastener may bealternately oriented relative to each other, for example, offset,bi-axial, etc. Further, it will be understood that the variousembodiments may be used in additional procedures not described herein,such as vascular trauma, arterial dissections, artificial heart valveattachment and attachment of other prosthetic device within the vascularsystem and generally within the body.

The preferred embodiments of the invention are described above in detailfor the purpose of setting forth a complete disclosure and for the sakeof explanation and clarity. Those skilled in the art will envision othermodifications within the scope and sprit of the present disclosure.

1. A method comprising providing a plurality of tissue-piercingfasteners, providing a tissue fastener applier, providing a directingdevice, and introducing the tissue fastener applier to apply singletissue-piercing fasteners to a prosthesis in a body organ sequentiallyalong a path established by the directing device that, between fastenerapplications, is manipulated into orientation with different desiredfastening sites, until a plurality of tissue-piercing fasteners areplaced, one-at-a-time, in the prosthesis.
 2. A method according to claim1 wherein at least one of the tissue-piercing fasteners comprises ahelical tissue-piercing fastener.
 3. A method according to claim 1wherein at least one of the tissue-piercing fasteners comprises afastener that pierces tissue in response to rotation, and wherein thetissue fastener applier includes a rotary driver.
 4. A method accordingto claim 1 wherein the plurality of tissue-piercing fasteners areintroduced in a circumferentially spaced-apart pattern at the differentdesired fastening sites in the prosthesis.
 5. A method according toclaim 1 wherein the directing device includes a deflectable distalregion.
 6. A method according to claim 1 wherein the directing deviceincludes a passage accommodating the fastener applier.
 7. A methodaccording to claim 6 wherein the passage comprises an interior lumen. 8.A method according to claim 1 further including, between fastenerapplications, reloading a single tissue-piercing fastener in the tissuefastener applier.
 9. A method according to claim 1 further including,between fastener applications, reloading a single tissue-piercingfastener in the tissue fastener applier at a remote access location. 10.A method according to claim 1 wherein the tissue fastener appliercarries the plurality of tissue-piercing fasteners.
 11. A methodcomprising providing a plurality of tissue-piercing fasteners, providinga tissue fastener applier, providing a directing device, and introducingthe tissue fastener applier to apply single tissue-piercing fasteners ina body organ sequentially along a path established by the directingdevice that, between fastener applications, is manipulated intoorientation with different desired fastening sites, until a plurality oftissue-piercing fasteners are placed, one-at-a-time, in the body organ.12. A method according to claim 11 wherein at least one of thetissue-piercing fasteners comprises a helical tissue-piercing fastener.13. A method according to claim 11 wherein at least one of thetissue-piercing fasteners comprises a fastener that pierces tissue inresponse to rotation, and wherein the tissue fastener applier includes arotary driver.
 14. A method according to claim 11 wherein the pluralityof tissue-piercing fasteners are introduced in a circumferentiallyspaced-apart pattern at the different desired fastening sites in theprosthesis.
 15. A method according to claim 11 wherein the directingdevice includes a deflectable distal region.
 16. A method according toclaim 11 wherein the directing device includes a passage accommodatingthe fastener applier.
 17. A method according to claim 16 wherein thepassage comprises an interior lumen.
 18. A method according to claim 11further including, between fastener applications, reloading a singletissue-piercing fastener in the tissue fastener applier.
 19. A methodaccording to claim 11 further including, between fastener applications,reloading a single tissue-piercing fastener in the tissue fastenerapplier at a remote access location.
 20. A method according to claim 11wherein the tissue fastener applier carries the plurality oftissue-piercing fasteners.
 21. A system comprising: an intraluminaldirecting device sized and configured for introduction from a remoteaccess site to a location within a body organ, the intraluminaldirecting device including a deflectable distal region sized andconfigured for manipulation to orient the distal region with respect toa range of different desired fastening sites within a body organ, and anintraluminal fastener applier sized and configured to be introduced andwithdrawn along the intraluminal directing device, the intraluminalfastener applier including a driven component sized and configured (i)to receive a single tissue-piercing fastener at the remote access siteoutside the intraluminal directing device, (ii) to be operated, afterintroduction of the intraluminal fastener applier along the intraluminaldirecting device to one of the desired fastening sites, to introduce thesingle tissue-piercing fastener into tissue at the desired one of thefastening sites, and (iii) to receive at the remote access site, afterwithdrawal of the intraluminal fastener applier along the intraluminaldirecting device, another single tissue piercing fastener, theintraluminal fastener applier accommodating (ii) and (iii) repeatedly,in concert with manipulation of the deflectable distal region of theintraluminal directing device with respect to a range of differentdesired fastening sites, until a desired plurality of tissue-piercingfasteners are introduced into tissue at different desired fasteningsites within the body organ.
 22. A system according to claim 21 whereinthe tissue-piercing fastener comprises a helical tissue-piercingfastener.
 23. A system comprising an intraluminal directing device sizedand configured for introduction from a remote access site to a locationwithin a body organ, the intraluminal directing device including adeflectable distal region sized and configured for manipulation toorient the distal region with respect different desired fastening siteswithin the body organ, and an intraluminal fastener applier sized andconfigured to be introduced along the intraluminal directing device, theintraluminal fastener applier including a driven component sized andconfigured to be operated, after introduction of the intraluminalfastener applier along the intraluminal directing device, to introduce aplurality of tissue-piercing fasteners into tissue one-at-a-time todesired fastening sites in concert with manipulation of the deflectabledistal region of the intraluminal directing device to different desiredfastening sites, until a plurality of tissue-piercing fasteners areintroduced into tissue at different desired fastening sites within thebody organ.
 24. A system according to claim 23 wherein at least one ofthe plurality of tissue-piercing fasteners comprises a helicaltissue-piercing fastener.